A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic complete responders will receive irradiation to the breas...
Gender
ALL
Eligibility criteria
- • Patients must have a histologically documented diagnosis of mammary carcinoma and evaluable disease in the breast.
- • Diagnostic tissue must be reviewed at NIH.
- • All ICB patients must meet Haagensen's clinical criteria of ICB.
- • Patients with metastatic breast cancer must have evaluable disease.
- • There must be no history of prior cytotoxic therapy.
- • There must be no history of previous malignancy except for cured nonmelanoma skin cancer and cervical carcinoma in situ.
- • Performance status (Karnofsky scale) must be greater than 30 for patients with metastatic breast cancer.
- • Staging workup must be negative for distant metastases in Stage III patients.
- • WBC count greater than 4000 per mm(3) and platelet count greater than 100,000 per mm(3).
- • Normal hepatic and renal function, unless due to tumor involvement.
- • Patients must be willing to give informed consent and be geographically accessible for follow up.
- • No history of other malignant neoplasms except for curatively treated nonmelanoma skin cancer or surgically cured carcinoma of the cervix in situ.
- • Patients must not be poor medical or psychiatric risks because of non-malignant systemic disease which would preclude them being subjected to any of the treatments in this protocol.
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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